AgingResearch.NewsJoin free

Phase 1Completed

Fasting Bioequivalence Study of Memantinol 20 mg Tablets Versus Akatinol Memantine® 20 mg Tablets In Normal Healthy Subjects

A Two-way Crossover, Open-label, Single-dose, Fasting, Bioequivalence Study of Memantinol® (JSC "GEROPHARM", Russia) 20 mg Tablets Versus Akatinol Memantine® (Merz Pharma GmbH & Co. KGaA, Germany) 20 mg Tablets in Normal Healthy Subjects

Sponsor
Geropharm (Industry)
Enrolment
18 enrolled
Conditions
Bioequivalence, AUC, Cmax, Pharmacokinetics
Interventions
Memantinol tablets, 20 mg; Akatinol Memantine® tablets, 20 mg
Ages
adults
Registry
NCT03121820

Full record on ClinicalTrials.gov

From the registry

This study are two-way crossover, open-label, single-dose, fasting, bioequivalence study of Memantinol® (JSC "GEROPHARM", Russia) 20 mg tablets versus Akatinol Memantine® (Merz Pharma GmbH \& Co. KGaA, Germany) 20 mg tablets in normal healthy subjects

Primary outcomes

  • Pharmacokinetics of Memantinol by Assessment of Area Under the Curve From Time Zero Extrapolated to Infinity (AUC(0-inf))
  • Pharmacokinetics of Memantinol by Assessment of Observed Maximum Plasma Concentration (Cmax)

History

  1. Results first posted

  2. Last registry update

  3. Registered

  4. Primary completion

  5. Started